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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01369342




Registration number
NCT01369342
Ethics application status
Date submitted
7/06/2011
Date registered
8/06/2011
Date last updated
6/01/2017

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)
Secondary ID [1] 0 0
CNTO1275CRD3002
Secondary ID [2] 0 0
CR018418
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Inflammatory Bowel Disease 0 0
IBD 0 0
Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Group 1: Placebo
Treatment: Drugs - Group 2 ustekinumab 130 mg
Treatment: Drugs - Group 3: ustekinumab approximately 6 mg/kg

Placebo Comparator: Placebo IV - Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.

Experimental: Ustekinumab 130 milligram (mg) - Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.

Experimental: Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg) - Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg) 390 mg (weight > 55 kg and <= 85 kg) and 520 mg (weight > 85 kg).


Treatment: Drugs: Group 1: Placebo
Form=solution for injection, route=intravenous use, in a single dose.

Treatment: Drugs: Group 2 ustekinumab 130 mg
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.

Treatment: Drugs: Group 3: ustekinumab approximately 6 mg/kg
Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Response at Week 6 - Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
Timepoint [1] 0 0
Week 6
Secondary outcome [1] 0 0
Number of Participants in Clinical Remission at Week 8 - Clinical remission at Week 8 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points.
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Number of Participants in Clinical Response at Week 8 - Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6 - 70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Timepoint [3] 0 0
Week 6
Secondary outcome [4] 0 0
Number of Participants With CDAI 70 Point Response at Week 3 - 70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Timepoint [4] 0 0
Week 3

Eligibility
Key inclusion criteria
- Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or
ileocolitis, confirmed at some time in the past by radiography, histology, or
endoscopy

- Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI)
score of >= 220 and <= 450, with confirmation of active inflammation

- Has failed conventional therapy as demonstrated by having received corticosteroids
and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a
history of failure to respond to or tolerate an adequate course of corticosteroids
and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is
corticosteroid dependent or has had a history of corticosteroid dependency AND Has not
previously demonstrated failure of or intolerance to 1 or more TNF-antagonist
therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria

- Have screening laboratory test results within protocol-specified parameters
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have had any kind of bowel resection within 6 months

- Are pregnant or planning pregnancy (both men and women) while enrolled in the study or
for 20 weeks after receiving study agent

- Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks
before the first administration of study drug

- Patients with certain complications of Crohn's disease that would make it hard to
assess response to study drug

- Patients with a history of or ongoing chronic or recurrent infectious disease

- Patients who have previously received a biologic agent targeting IL-12 or IL-23,
including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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- Liverpool
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- Malvern
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- Parkville
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study (UNITI-2) will compare the effects (both positive and negative) of an initial
treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely
active Crohn's disease.
Trial website
https://clinicaltrials.gov/show/NCT01369342
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications